Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-09-02FDA-DeviceSiemens Medical Solutions USA, IncClass IICios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
- 2020-09-02FDA-DeviceSiemens Medical Solutions USA, IncClass IICios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).
- 2020-09-02FDA-DeviceMaterialise N.V.Class IIMatch Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
- 2020-09-02FDA-DeviceCanon Medical System, USA, INC.Class IISystem Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
During a procedure, when images were acquired, and these images were transferred to PACS /image archival system, the number of images displayed were not the same as originally acquired.
- 2020-09-02FDA-DeviceThe Magstim Company LimitedClass IINeurosign V4 Intraoperative Nerve monitor family of devices.
Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.
- 2020-09-02FDA-DeviceGE Healthcare, LLCClass IICARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
- 2020-09-02FDA-DeviceKlarity Medical Products LLCClass IIKlarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
- 2020-09-02FDA-DeviceBiosense Webster (israel), Ltd.Class IICARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure, Product Number: -5400-00, UDI: 10846835000870
Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely rare circumstances, cardiac perforation.
- 2020-09-02FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS XT7600 Integrated System, Product code 6844461
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
- 2020-09-02FDA-DeviceOrtho Clinical DiagnosticsClass IIVITROS XT3400 Chemistry System, Product code 6844458
When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result, certain VITROS MicroSlides may produce erroneous results.
- 2020-09-02FDA-DeviceOraSure Technologies, Inc.Class IIIOrasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
- 2020-09-02FDA-DeviceOraSure Technologies, Inc.Class IIIOrasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
- 2020-09-02FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
- 2020-09-02FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
- 2020-09-02FDA-DeviceOrtho-Clinical DiagnosticsClass IIVITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- 2020-09-02FDA-DeviceGlobus Medical, Inc.Class IIALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
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